Renal Denervation in Patients With Chronic Heart Failure With Preserved Ejection Fraction

NCT05715697 | Recruiting DMC

• 1 other identifier: 20230126-03
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to explore the potential of RDN as a therapy for HFpEF in a Prospective, Multicenter, Randomized, Blinded, Sham-controlled Study.

Conditions

Heart Failure With Preserved Ejection Fraction; Renal Denervation

Outcome Measures

Primary Outcomes (1)

• Change from baseline E/E' at 12 months

  Echocardiography will be used to measure the E/E'

  12 months after treatment

Secondary Outcomes (1)

• Number of participants with adverse events

  1 year

Study Arms (2)

Renal denervation and maintenance of heart failure medications

EXPERIMENTAL

Renal denervation in patients with HFpEF and uncontrolled hypertension

Procedure: Renal denervation and maintenance of heart failure medications

Sham intervention, maintenance of heart failure medications

SHAM COMPARATOR

Sham Treatment. After 1 year, cross-over is planned in all sham-treated patients and this patients will also receive a renal denervation.

Procedure: Sham procedure and maintenance of heart failure medications

Interventions

Sham procedure and maintenance of heart failure medications PROCEDURE

Sham intervention, maintenance of heart failure medications

Sham intervention, maintenance of heart failure medications

Renal denervation and maintenance of heart failure medications PROCEDURE

Renal denervation and maintenance of heart failure medications

Renal denervation and maintenance of heart failure medications

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• signs or symptoms of heart failure;
• normal or mildly abnormal systolic LV function (LVEF ≥ 50%);
• evidence of diastolic LV dysfunction.
• Individual should fulfill the diagnostic WHO criteria for hypertension: SBP \> 140 mmHg and/or DBP \> 90 mmHg, and is treated with at least 2 antihypertensive drugs. This treatment is expected to be maintained for at least 6 months. Using this regimen the blood pressure should be adequately controlled (\< 140/90mmHg by 24 hour ambulatory BP measurement).
• Individual is adhering to a stable drug regimen HFNEF, with no changes for a minimum of 2 weeks prior to enrollment, and which is expected to be maintained for at least 6 months.

You may not qualify if:

• Known secondary cause of hypertension
• Anatomy not eligible for renal denervation
• Systolic heart failure (LVEF \< 50%)
• Individual has an estimated glomerular filtration rate (eGFR) of \< 30mL/min/1.73m2, using the MDRD calculation.
• Individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, haemophilia, significant anaemia, or arrhythmias such as atrial fibrillation).
• Individual is pregnant, nursing or planning to be pregnant.

Sponsors & Collaborators

• Xinjiang Medical University: lead
• First Affiliated Hospital of Xinjiang Medical University: collaborator

Study Sites (1)

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830000, China

RECRUITING

Central Study Contacts

Xiang Xie

CONTACT

+869914366892; xiangxie999@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Hypertension Department, Clinical Professor

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: February 8, 2023
• Study Start: September 1, 2023
• Primary Completion: September 1, 2024
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 1, 2024

Record last verified: 2024-01

Locations

CN (1)